N/A
N=49
Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT03436147 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Recurrence of Pelvic Organ Prolapse — 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- POP-Q (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Recurrence of Pelvic Organ Prolapse |
0; 0 | — |
| SECONDARY POP-Q SYSTEM Point C MEASUREMENT |
-8.5; -7 | — |
| SECONDARY ICIQ-VS Vaginal Symptom Subscale |
-13.8; 17.7 | — |
Summary
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on patient-centered medicine and patient-generated definitions of surgical success has resulted in reassessment of uterine preservation versus hysterectomy at the time of apical POP repair. Various techniques have been described for uterine preserving prolapse surgery, which may include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was introduced and a series of 70 women was reported. To date, there have been no randomized studies comparing the outcomes of vaginal assisted laparoscopic uterine suspension (hysteropexy) with conventional vaginal hysterectomy. Women attending the gynecology clinic at a tertiary referral urogynecology unit in tertiary referral training and research hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse will be offered participation in a randomized trial, over a 2-year period. Subjects participating in the study were randomly assigned to either of two groups: Group A, Vaginally Assisted Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and Mc Call Culdoplasty (VH + Mc Call).1 year following surgery, vaginal prolapse will be assessed again using the International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS) questionnaire and the Pelvic Organ Prolapse -Quantification (POP-Q) examination by another researcher then the operator.
Eligibility Criteria
Inclusion Criteria
- patients who are over 35 years of age with no desire to preserve fertility. (Subjects had completed childbearing or were practicing reliable contraception)
- have a normal size uterus (<10 cm) on examination or ultrasound
- who agree to participate in principle will be given further information about the trial and consent will be obtained either in an outpatient clinic or at the next visit for preoperative assessment.
Exclusion Criteria
- cervical elongation (surgeon discretion),
- prior mesh prolapse repair,
- current foreign-body complications,
- increased risk or recent history of cervical dysplasia, chronic pelvic pain, significant uterine abnormalities, and abnormal menstruation.
- postmenopausal bleeding in the past 12 months
- women with a significantly enlarged fibroid uterus
- concomitant medical problems precluding general anesthesia or the use of a steep trendelenberg position
Data sourced from ClinicalTrials.gov (NCT03436147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.